Medical Device Manufacturing Equipment Engineer

Nextern; Maple Grove (MN); Sur place; USD 75 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health plan

401(k) with company match

Paid time off

Birthday holiday

Life Insurance

Résumé du poste

Nextern is seeking a Manufacturing Equipment Engineer 2 to own the equipment and inspection-equipment lifecycle for our manufacturing lines, including specifications, drawings, PM programs, fixture/tooling ownership, and new equipment qualification. The role focuses on precision metrology such as laser micrometers and dimensional gauging.

Successful candidate will bring 3–5 years of experience with production equipment in regulated environments, familiarity with IQ/OQ/PQ, TMV, Gage R&R, and CAD

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or related technical field.

Responsabilités

• Own and maintain equipment specifications, drawings, and documentation for production equipment, fixtures, and tooling.
• Build and run a preventive maintenance program for line equipment with PM schedules and spare-parts planning.
• Own fixture and tooling design, qualification, and lifecycle management.
• Lead specification, vendor evaluation, and qualification of new inspection and metrology equipment.
• Support Test Method Validation (TMV) and IQ/OQ/PQ activities, including Gage R&R studies.
• Maintain a prioritized equipment-sustaining backlog and escalate long-lead needs.
• Partner with Manufacturing Engineering on root-cause investigations where equipment is a factor.
• Execute other duties and projects as assigned.

Connaissances

Equipment ownership

Preventive maintenance

Metrology & inspection

Gage R&R

GD&T

CAD (SolidWorks)

IQ/OQ/PQ validation

Formation

Bachelor’s degree in Mechanical/Electrical/Manufacturing Engineering

Outils

Mitutoyo/Keyence/LaserLinc metrology tools

SolidWorks CAD

Description du poste

Nextern is seeking a Manufacturing Equipment Engineer 2 to own the equipment and inspection-equipment lifecycle for our manufacturing lines, including specifications, drawings, PM programs, fixture/tooling ownership, and new equipment qualification. The role focuses on precision metrology such as laser micrometers and dimensional gauging.

Successful candidate will bring 3–5 years of experience with production equipment in regulated environments, familiarity with IQ/OQ/PQ, TMV, Gage R&R, and CAD